FDA Clarifies Criteria for Competitive Generic Therapy Designation

March 24, 2020

The FDA has clarified its criteria for granting a competitive generic therapy (CGT) designation. The agency can designate a generic as a CGT if there is no more than one approved drug listed in the active section of the Orange Book.

Once designated, a generic will remain designated a CGT even if there is no longer inadequate generic competition for that drug prior to the ANDA’s approval, the agency said.

A CGT designation might not result in an earlier GDUFA decision date, but the agency intends to prioritize the applications and it may expedite reviews of the generics.